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Stryker recalls replacement hip cups from Ireland plant

JonKamp

Stryker Corp.
SYK, +0.67%
has voluntarily recalled two replacement hip cups under its popular "Trident" line made at plant in Ireland due to concerns about "manufacturing residuals" on the products that exceeded company standards.

The issue doesn't affect the sterility of the "Trident Acetabular PSL and Hemispherical Cups" or mean that patients who have a Trident replacement hip from Stryker need worry, according to the Kalamazoo, Mich., company. Stryker said in a release Tuesday that it "anticipates some short-term supply disruption" due to the recall, but has ramped up production in response and doesn't expect a material financial impact on its total 2008 guidance.

Acetabular cups are used in the socket portion of replacement hip components, and the Trident products are Stryker's most contemporary cups. The PSL version is the most commonly used Stryker cup in the U.S.

Concerns with the Trident cups were cited in a warning letter to the company from the U.S. Food and Drug Administration that was issued in late November and made public last week, although that letter addressed issues at Stryker's Mahwah, N.J., facility, which isn't affected by this recall.

Stryker sought in Tuesday's release to address that warning letter due to what the company called "erroneous conclusions" in recent media reports. The FDA letter said Stryker failed to properly identify and correct recurring problems with some of its hip implants made at the Mahwah plant. Among other issues, the letter noted "continual complaints from January of 2005 through May of 2007" concerning Trident hip cups "that have failed to function" and hip components with poor fixation. The FDA noted that in some instances, patients needed revision surgeries.

"First and foremost, the company does not believe there is any clinical evidence to indicate that the products mentioned in the warning letter present a safety issue to patients," Stryker said in its release Tuesday.

It said that numerous published independent reports validate the long-term clinical performance of the products at issue.

The company also said it takes these matters very seriously and has been cooperating fully with the FDA.

An internal company probe launched in response to the FDA's observations led Stryker to find the issue with Trident hip cups made at the plant in Cork, Ireland. Specifically, Stryker said that its investigation confirmed that these Trident products met all U.S. and international performance standards for sterility and biocompatibility.

"However, results from that testing indicated that the level of manufacturing residuals in some cases exceeded the Company's internal acceptance criteria," the company said.

Stryker said that the issue "in no way impacts the product's sterility" and that medical expert opinion of current and historical data concludes that there are no safety issues for patients with these Trident hip parts. The recall impacts products on hospital shelves, rather than products already implanted.

The Trident cups are also made at the Mahwah plant, and those cups aren't affected by the voluntary recall. Stryker noted that shipments from Cork have already resumed following validation of the manufacturing process there. Production has been increased at both the Mahwah and Cork plants.

The company said last week that it was "investigating a potential deviation from our internal manufacturing specifications" for Trident hip cups at the Cork plant. Stryker confirmed it was looking into the issue shortly after an analyst noted in a research note that there was a "quarantine" on the products.

Stryker doesn't detail sales figures for its Trident replacement hip parts in its quarterly reports. Orthopedic implants are Stryker's biggest business, although it also derives a large portion of its revenue from its faster-growing medical and surgical equipment business. Through the first nine months of 2007, orthopedic implants accounted for about 60% of Stryker's $4.34 billion in net sales.

The company's big competitors in the market for replacement orthopedic joints, a huge and growing business fueled by an aging population that is wearing out original joints, include Zimmer Holdings Inc. (ZMH), Johnson & Johnson (JNJ) unit DePuy, privately held Biomet Inc. and U.K.-based Smith & Nephew PLC (SNN).

Stryker is scheduled to report fourth-quarter results and discuss its outlook for the current year on Wednesday.

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